MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA15 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number FX433T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that a valve blockage was found.The reporter indicated that the reservoir was blocked and revision was implemented.Per the reporter, when the surgeon tried to press the reservoir, it could not be pressed; there might be blockage with the connector.After taking out the reservoir and pumping it a few times, it worked properly.However, there might be something that caused blockage inside.Additional event details and patient information were not provided, however, have been requested.

Manufacturer Narrative

Investigation: visual inspection: in the first step of our investigations, an optical control is carried out.It is checked whether any defects, deformations or other noticeable irregularities can be identified permeability test: in order to prove the permeability of the control reservoir, we carried out a penetration test.By pumping the diaphragm, we checked whether the reservoir can be filled with the test fluid and whether it can be drained.The catheter is checked for permeability with a syringe filled with liquid.Result: first, we performed a visual inspection of the reservoir and catheter.Bloody residues were found on the reservoir.At the catheter, we could see that the peritoneal catheter and a piece of ventricular catheter connected with a connector.Next, we tested the permeability of the reservoir.By pumping and draining liquid it was checked whether the reservoir is permeable.The test result shows that the reservoir fills with liquid and is emptied again and thus permeable.In the next step, we also checked the peritoneal catheter for permeability.We found that the ligature on the connector was interfering with patency.Once the ligature was released, flow was possible but difficult.It was observed that bloody fluid was leaking.The ventricular catheter tested positive of permeability.In order to verify whether, that the catheter where by a build-up of natural substances (protein, blood or tissue particles) was affects, we have cut the catheter open.Inside the catheter, we found significant blood deposits.Based on our investigations, we confirm the presence of occlusion in the catheter, likely due to the deposits observed.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The product met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0 SYS W/SA15 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9701319
• MDR Text Key: 187788370
• Report Number: 3004721439-2020-00052
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX433T
• Device Catalogue Number: FX433T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 55